K033603

Substantially Equivalent

INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999

Applicant: Beckman Coulter, Inc.
Product code: LIG
Advisory panel: Clinical Chemistry
Date received: 2003-11-17
Decision date: 2003-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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